BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUMATCH CMF

    MDR report key: 22461588 · Received July 9, 2025

    Report

    Report Number
    3005718816-2025-00003
    Event Type
    Injury
    Date Received
    July 9, 2025
    Date of Event
    May 5, 2025
    Report Date
    June 17, 2025
    Manufacturer
    MATERIALISE USA, LLC.
    Product Code
    JEY
    UDI-DI
    05420060380013
    PMA / PMN Number
    K170272
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ONGOING; RC UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION CONCLUDED THAT THE DEVICES DID NOT MALFUNCTION AND THERE WAS NO DETERIORATION IN THE CHARACTERISTICS OF THE PERFORMANCE, AND AS SUCH THE DEVICES MET SPECIFICATIONS. THE EXACT REASON FOR REPORTED ISSUE COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    SURGERY WAS COMPLETED AS USUAL BUT POST-OPERATION WAS NOT AS EXPECTED. THE PATIENT HAS A CLASS 2 OCCLUSION INSTEAD OF PLANNED CLASS 1 OCCLUSION. REDO SURGERY NEEDED TO CORRECT OCCLUSION.

    Description of Event or Problem · 0

    SURGERY WAS COMPLETED AS USUAL BUT POST-OP WAS NOT AS EXPECTED. THE PATIENT HAS A CLASS 2 OCCLUSION INSTEAD OF PLANNED CLASS 1 OCCLUSION. REDO SURGERY NEEDED TO CORRECT OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168199 TRUMATCH CMF TRUMATCH ORTHOGNATHIC - FULL BIMAXILLARY SURGICAL KIT JEY MATERIALISE USA, LLC. SD980.001 MU25UGAVIP 05420060380013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other